Baclofen

Product NDC
63187-313
11-digit product format
631870313
Labeler code
63187
Product ID
63187-313_83a0b967-118f-4459-ad38-1ec6a769dcc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
baclofen
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077241
Marketing category
ANDA
Marketing start
2005-12-01
Substance
BACLOFEN
Active strength
10 mg/1
Pharmacologic classes
GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077241-001BACLOFENBACLOFEN20MGTABLET / ORALAB2005-12-20
A077241-002BACLOFENBACLOFEN10MGTABLET / ORALAB2007-07-06
A077241-003BACLOFENBACLOFEN5MGTABLET / ORALAB2021-09-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077241-001AB
A077241-002AB
A077241-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 115 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077241-002BACLOFEN10MGTABLET / ORALAB2007-07-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077241-003BACLOFEN5MGTABLET / ORALAB2021-09-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077241-001BACLOFEN20MGTABLET / ORALAB2005-12-208072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 115 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077241-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077241-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077241-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077241-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077241-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077241-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077241-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077241-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077241-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077241-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077241-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077241-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077241-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077241-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077241-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077241-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077241-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077241-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077241-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077241-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077241-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077241-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077241-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077241-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077241-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077241-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077241-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077241-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077241-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077241-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077241-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077241-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077241-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077241-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077241-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077241-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077241-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077241-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077241-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077241-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Baclofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACLOFEN10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H789N3FKE8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197391Internal RxNorm lookup
197392Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
924a01fb-0ed0-4f73-9304-d6c5b9961d66Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e25d01b-2e92-4765-bec7-8a0fd7bdc346Product name220251208
1b1393e5-f2d8-42f5-a070-e3416d619667Product name120250804
88583480-702d-4dfe-a31c-9c00abd818f8Product name720250729
1cf3c538-592e-4b4b-869e-51d4bf3ca83dProduct name220240703
6e532d1f-e0b5-46eb-a2be-d70bd338df9dProduct name120220613
ef6bc0bf-8134-f06b-70d9-4980df6f808eProduct name520210615
eeec0918-7a2f-44bf-83d6-1216e507adbfProduct name320191217
a5300adb-f538-4abb-a49e-f8f0b8d9ac75Product name120190611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-313-20Baclofen20 in 1 BOTTLE, PLASTICTABLET208
63187-313-30Baclofen30 in 1 BOTTLE, PLASTICTABLET308
63187-313-60Baclofen60 in 1 BOTTLE, PLASTICTABLET608
63187-313-72Baclofen120 in 1 BOTTLE, PLASTICTABLET1208
63187-313-78Baclofen180 in 1 BOTTLE, PLASTICTABLET1808
63187-313-90Baclofen90 in 1 BOTTLE, PLASTICTABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-313-20EA - Each63187-3131316dfea-24c8-4234-8cfe-8bfa0849183012023-08-08
63187-313-30EA - Each63187-313f1838a5d-2bb3-4dab-8320-b0ebd9835a7112016-09-02
63187-313-60EA - Each63187-3138edeb3f6-23dd-4d4f-ae83-f07183e5d36b12017-08-11
63187-313-72EA - Each63187-313b8d8c7cd-c31d-4754-8d29-8dc9f01b708a12017-06-15
63187-313-78EA - Each63187-3139247b117-3d33-4d7b-9689-41380cf2748812018-05-09
63187-313-90EA - Each63187-313881a980f-2add-402b-bb15-43e6ed7099b412016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACLOFENACTIVE INGREDIENTH789N3FKE8BACLOFEN TABLET [PROFICIENT RX LP]2
BACLOFENACTIVE MOIETYH789N3FKE8BACLOFEN TABLET [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBACLOFEN TABLET [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BACLOFEN TABLET [PROFICIENT RX LP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BACLOFEN TABLET [PROFICIENT RX LP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBACLOFEN TABLET [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-313BACLOFEN TABLET [PROFICIENT RX LP]8Current NDC, Legacy NDC, 6 package rows20200505_924a01fb-0ed0-4f73-9304-d6c5b9961d66.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BaclofenBACLOFENCardinal Health 107, LLC2278954a-7605-426a-ae85-1bf0a31174202026-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241
BaclofenBACLOFENMajor Pharmaceuticalsae732bdc-5178-4565-8219-d1787a5211a62026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241
BaclofenBACLOFENPD-Rx Pharmaceuticals, Inc.cfcf519f-5d15-431d-89c8-961a0c38ba602025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241
BaclofenBACLOFENMarlex Pharmaceuticals Inc1b0f50c8-62e3-414d-96d3-5fd16e8043ab2025-09-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241
BaclofenBACLOFENAdvanced Rx Pharmacy of Tennessee, LLCb4f2f888-979a-6f54-e053-2a95a90a95a32024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241
BaclofenBACLOFENChartwell RX, LLC2a75db96-590a-43cf-aefb-3bbcb287dbf02024-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241
BaclofenBACLOFENBryant Ranch Prepack7f27f935-b1fa-4494-9014-7f62c59bb8e32024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241
BaclofenBACLOFENBryant Ranch Prepackb4506087-be24-4e76-9fb8-b078051370722024-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241
BaclofenBACLOFENAphena Pharma Solutions - Tennessee, LLCc582972d-22ef-4326-b37f-adf2ca0b18752023-12-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241
BaclofenBACLOFENBryant Ranch Prepack58816b46-28a5-48e2-b89d-98df659393862023-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241
BaclofenBACLOFENBryant Ranch Prepack9110b1cb-8604-4824-9337-84b08d41dd3c2023-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241
BaclofenBACLOFENLannett Company, Inc.f84f3f4c-17e6-43f1-9600-63b0b175837b2021-02-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241
BaclofenBACLOFENProficient Rx LP924a01fb-0ed0-4f73-9304-d6c5b9961d662020-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077241
application number: ANDA077241
ndc (product): 63187-313

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197391baclofen 10 MG Oral TabletPSN924a01fb-0ed0-4f73-9304-d6c5b9961d668
197392baclofen 20 MG Oral TabletPSN924a01fb-0ed0-4f73-9304-d6c5b9961d668
197391baclofen 10 MG Oral TabletSCD924a01fb-0ed0-4f73-9304-d6c5b9961d668
197392baclofen 20 MG Oral TabletSCD924a01fb-0ed0-4f73-9304-d6c5b9961d668

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-313-206318703132020 TABLET in 1 BOTTLE, PLASTIC (63187-313-20) 20 tablet2018-10-010000-00-00NoNoCurrent
63187-313-306318703133030 TABLET in 1 BOTTLE, PLASTIC (63187-313-30) 30 tablet2014-05-010000-00-00NoNoCurrent
63187-313-606318703136060 TABLET in 1 BOTTLE, PLASTIC (63187-313-60) 60 tablet2014-05-010000-00-00NoNoCurrent
63187-313-7263187031372120 TABLET in 1 BOTTLE, PLASTIC (63187-313-72) 120 tablet2017-03-010000-00-00NoNoCurrent
63187-313-7863187031378180 TABLET in 1 BOTTLE, PLASTIC (63187-313-78) 180 tablet2018-03-010000-00-00NoNoCurrent
63187-313-906318703139090 TABLET in 1 BOTTLE, PLASTIC (63187-313-90) 90 tablet2014-05-010000-00-00NoNoCurrent